Vibigaba (germinated brown rice) and maintenance of normal blood cholesterol concentration: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

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Article
germinated brown rice, Vibigaba, blood cholesterol, health claim
First published in the EFSA Journal
21 July 2017
Adopted
27 June 2017
Type
Scientific Opinion
Abstract

Following an application from Loc Troi group, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Vibigaba (germinated brown rice) and contribution to the maintenance of normal blood cholesterol concentrations. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food proposed by the applicant as the subject of the health claim is Vibigaba. The Panel considers that the germinated brown rice Vibigaba is sufficiently characterised. The claimed effect proposed by the applicant is ‘contribution to the maintenance of normal blood cholesterol levels’. The Panel considers that maintenance of normal blood cholesterol concentrations is a beneficial physiological effect. The Panel notes that the applicant did not perform a comprehensive literature search to identify human intervention studies which could be pertinent to the claim. The applicant did not reply to a specific request from EFSA to provide this information. The applicant identified one human intervention study as being pertinent to the claim. The Panel notes the important methodological limitations of the study (e.g. statistical methods used for data analysis not appropriate for the study design) and that the information provided on the design and conduct of the study is insufficient for a complete scientific evaluation. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of Vibigaba (germinated brown rice) and maintenance of normal blood cholesterol concentration.

Panel members at the time of adoption
Jean-Louis Bresson, Barbara Burlingame, Tara Dean, Susan Fairweather-Tait, Marina Heinonen, Karen Ildico Hirsch-Ernst, Inge Mangelsdorf, Harry J McArdle, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Kristina Pentieva, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Daniel Tomé, Dominique Turck, Hendrik Van Loveren, Marco Vinceti and Peter Willatts.
Panel on Dietetic Products, Nutrition and Allergies
Contact
nda [at] efsa.europa.eu
doi
10.2903/j.efsa.2017.4913
EFSA Journal 2017;15(7):4913 [9 pp.].
Question Number
On request from
Competent Authority of the Netherlands following an application by Loc Troi Group
Print on demand
Number of Pages
9